Ich bin davon ausgegangen, falls die P3 alle gewünschten Endpunkte trifft, ca. im August 2024 veröffentlicht werden und Zulassungsantrag bis Nov `24 eingerreicht wird und dann Ende 2025 die erweitere Zulassung von Bylvay in Biliary Atresia erfolgt. Dann würde der CRV für mich Sinn ergeben. Aber, nachdem ich die Telefonkonferenz bei Ipsen nachgelesen habe, klang das anders, als es bei Albo im Pressebericht stand.
Text Albo: Each CVR will entitle its holder to deferred cash payments of $10.00 per CVR payable upon the U.S. Food and Drug Administration (FDA) approval of Bylvay in the Biliary Atresia indication at the latest by 31 December 2027, allowing for a potential increase in the number of patients in the BOLD study.
Telefonkonferenz Ipsen: Auszüge zu BA und CRV
Kasai surgery or a hepatoportoenterostomy can be life-saving in patients that respond. However, about 50% of patients undergo a liver transplant in the first two years of life. BOLD is a double-blind randomized placebo-controlled trial to evaluate the safety and efficacy of Bylvay in children who have biliary atresia and have undergone a Kasai procedure before age three months and who are eligible to start treatment and randomize within three weeks of the procedure.
The primary efficacy endpoint is the proportion of patients who are alive and have not undergone a liver transplant after two years in the Bylvay arm compared to placebo. The study has enrolled 205 patients. And based on our due diligence, we are confident in the trial design and may increase the sample size of the study to maximize its probability of success. The FDA and EMA have indicated that a single pivotal study is sufficient to support filing.
The agreement has been structured to include a contingent-value payment based on the approval of Bylvay in biliary atresia in the U.S. by FDA. One contingent-value right per share will entitle its holder to a deferred cash payment of $10 per CVR, which will represent about $240 million. As you can see, this transaction will be fully financed by our existing available cash and line of credit. And we will keep, after the transaction, sufficient firepower to continue our business development strategy.
And then, is there any timeline to the CVR? Is there any sort of point in time where the CVR expires regardless of what happens with the approval or is it open-ended?
Yeah, so as you can see, from the press release, the drop date for the CVR is end of December of 2027, as we have room to potentially adjust the number of patients in the — study and that so what explains that is the way to maximize the probability of success of that study, which represents a large part of 50% of the 800 million B-cell.
The answer is no. The CVR is not going to be tradable.
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.. das Veröffentlichungsdatum für den CVR ist Ende Dezember 2027, da wir dann den Spielraum haben, um die Anzahl der Patienten in der Studie möglicherweise anzupassen, und das erklärt das so um die Erfolgswahrscheinlichkeit dieser Studie zu maximieren, die einen großen Teil von 50 % der 800 Millionen darstellt. In meinen Augen weicht das mächtig ab, weil bei Albo davon keine Rede war, dass die die Studie anpassen können. Wir als Altaktionäre gehen doch von der vorhandenen Studie ohne einer Anpassung aus. Und da steht in der Timeline: Estimated Primary Completion Date : May 2024 Estimated Study Completion Date : June 2024
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